(29 days)
This device is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nursing Station. The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.
It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.
The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis. It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.
This document is a 510(k) clearance letter from the FDA for the AIDA Compact II device. It does not contain information about the device's acceptance criteria or any study details. The letter states that the device is a "Picture archiving and communications system" and is intended for use in recording and archiving image sequences and patient data during diagnostic or therapeutic procedures for viewing and reference purposes, not for primary diagnosis.
Therefore, I cannot provide details on the acceptance criteria or study that proves the device meets them based on the provided text. The document's purpose is to grant market clearance, not to detail the technical validation of the device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).